YAN Jing-ying (顏景穎), WANG Hui-min (汪慧敏), CHEN Bao-sen (陳保森),CHEN Shuo (陳 爍), ZHONG Yuan-shuai (鐘元帥)

Beijing University of Chinese Medicine Shenzhen Hospital, Shenzhen 518172, China

ABSTRACT Objective:To explore the application effect of TCM multimodal analgesia rapid rehabilitation strategies in perioperative period of hemorrhoids. Methods:A total of 90 patients with mixed hemorrhoid who received traditional Milligan-Morgan surgical treatment from May 2018 to April 2019 in our hospital were selected. They were randomly divided into the control group and treatment group according to different analgesic strategies, with 45 cases in each group. The control group was given western medicine of analgesia, and the treatment group was given TCM multimodal of analgesia. The visual analogue scale(VAS) in the 2 groups after analgesic strategies were analyzed and compared to explore its effect and evaluate its application value. Results:From the 2nd day to the 7th day after the operation, VAS scores in the treatment group were lower than those in the control group, with statistically significant differences (P＜0.05).The overall analgesic efficiency in the treatment group was higher than the control group. The incidence of postoperative complications was lower than the control group, and the hospitalization time was significantly shortened, with statistically significant differences (P＜0.05). Conclusion: Compared with the western analgesic strategy, the pain of hemorrhoid patients treated by TCM multimodal analgesia was significantly relieved after hemorrhoid surgery. The rapid recovery strategy has fewer postoperative complications, quick recovery, patient satisfaction, and remarkable results.

KEYWORDS TCM multi-mode analgesia; Hemorrhoid; Rapid recovery strategy

Traditional Chinese Medicine (TCM) multimodal analgesia is a new analgesic strategy derived from the concept of rapid rehabilitation surgery that can significantly alleviate the traditional postoperative pain of mixed hemorrhoids. The incidence of mixed hemorrhoids is high, and there are many complications in traditional surgery.The side effects of western medicine are strong,and patient satisfaction is low. The anorectal professional group of our hospital has set up a special subject for research on how to solve this series of problems. We found that TCM multimodal analgesic method with the external use of TCM with TCM appropriate technology can significantly relieve the pain after hemorrhoid surgery. Based on this, the treatment effect in 90 patients who have used this method was reported as follows.

MATERIALS AND METHODS

Diagnostic Criteria

Refer toClinical Diagnosis and Treatment Guidelines for Mixed Hemorrhoids(2006 Edition)[1].

Inclusion Criteria

Patients are compliant with the diagnosis and mainly with damp-heat syndrome; age 18 to 65 years old. There was no serious underlying disease,no history of anal surgery, feasible of Milligan-Morgan surgery under spinal anesthesia; and the surgical incision is expected to be 2 to 4; Patients can tolerate and be voluntary to surgery.

Exclusion Criteria

Patients with other anorectal diseases and diseases that affect wound healing; pregnant,breastfeeding, and menstrual women; those with allergies; alcohol or drug abusers; those who cannot follow up on schedule or have poor compliance;patients who are participating in other clinical trials.

General Information

Ninety cases came from hospitalized diagnosed with mixed hemorrhoids in our department from August 2018 to April 2019. They were randomly divided into the treatment group and control group,with 45 cases in each group. Seniors and above were in charge of the operation. The anesthesia method was waist anesthesia, and the operation method is mixed hemorrhoids external stripping and internal ligation. The control group included 21 males and 24 females; the treatment group included 22 males and 23 females. There was no significant difference between the 2 groups in terms of general case data, such as the course of disease,age, gender, hemorrhoid grade and number of hemorrhoids, and they were comparable (P>0.05)(See Table 1).

Treatment Methods

The control group

They are given oral administration of profenbeine sustained-release tablets: take it orally at 8 a.m. and 8 p.m. on the first postoperative day for 7 consecutive days.

Potassium permanganate liquid sitz bath: Start using 1:5 000 potassium permanganate sitz bath at 8:30 a.m. on the first postoperative day. The water temperature is about 40 ℃ for 10 minutes, once every 4 hours, continuous 3 times, for 7 days.

Medicine on the anus: diclofenac sodium suppository (50 mg/tablet). The suppository was placed on the anus at 9 a.m. and 3 p.m. on the first postoperative day. The treatment was performed by doctor, one table per time, for 7 consecutive days.

The treatment group

Ear-point pressing beans: stick beans 2 hours before the operation, on the ear-points of anus,rectum, sympathetic, subcortical, and Shenmen of one ear, and the patient press on its own for 60 s to produce soreness, numbness, swelling and pain,every 8 hours. The bean paste was changed every other day, and the ears were alternated for a total of 7 days of treatment.

Thread embedding at Chengshan acupoints (承山穴): it can be performed before the operation. After disinfecting the drape, pierce the embedding needle with catgut in the hand vertically into Chengshan acupoint. After fully embedding, the needle hole is pressed for dressing.

Chinese materia medica sitz bath: The Zhixiao Powder (痔消散) [the prescription agreed in the Department of Anorectal, Beijing University of Chinese Medicine, Shenzhen Hospital, modified Huanglian Jiedu Decoction (黃連解毒湯),confidentiality with specific information], start using at 7 a.m. on the first day after surgery, 1 bag (20 g/bag)per time, add 5,000 mL boiling water in a basin, firstly fumigate the anus with hot air, and sit in a bath until the water drops to 40 ℃, 10 minutes each time, once every 4 hours, 3 times continuously, lasting 7 days.

Electroacupuncture at Baliao points (電針八髎穴) [Shangliao (上髎), Ciliao (次髎), Zhongliao (中髎),Xialiao (下髎)].

Operation: Perform electroacupuncture at 10 a.m. on the first postoperative day. The patient keep the prone position. The doctor who has been fully trained and skilled in the operationwill take acupuncture points and connect to the electroacupuncture device, dilatational wave,50 Hz output frequency, continuous treatment for 30 minutes, continuous 7 days. Fasting is forbidden in treatment, and the patient can tolerate it. Any adverse reactions during treatment should be handled and recorded in time.

Table 1. Comparison of General Information Between the 2 Groups

Medicine on the anus: Mayinglong Shexiang Zhichuang Ointment (馬應龍麝香痔瘡膏). The medicine was applied to the anus at 9 a.m. and 15 p.m. on the first day after the operation, and the treatment was operated by the doctor, one piece each time, for 7 days.

Observation Indicators

Pain score at 6 h, 1 d, 2 d, 3 d, 5 d, 7 d after operation: VAS scores was used: 0 for no pain, 2 for slight pain, 4 for mild pain, 6 for moderate pain, 8 for severe pain and 10 for intolerable pain.

The overall effect of analgesia scores: the degree of pain was evaluated according to the 7thNational Anorectal Academic Conference, and the VAS scores. The proposed evaluation criteria were as follows: markedly effective (0VAS3 points,and T24maxVAS3 points); effective: (0VAS3 points, but T24maxVAS>3 points; 3＜VAS5 points and T24maxVAS5 points); invalid (3＜VAS＜5 points, but T24maxVAS>5 points, or VAS>5 points); Total effective rate=(number of markedly effective cases + number of effective cases/total number of cases)100%.

Scoring of postoperative complications: the wound edema, urinary retention, defecation, and sleep were scored (The score was set from 0 to 3 points).

The satisfaction of the 2 groups after treatment was observed.

Statistical Methods

The SPSS17.0 software package was used for statistical analysis. The measurement data usedttest, rank sum test, repeated measures analysis of variance; count data used chi-square test, etc.,P＜0.05 was considered as statistically significant difference.

RESULTS

The Comparison of the Pain Scores Between the 2 Groups

After repeated measurement analysis of variance, the pain score within 2-7d after the operation was tested;F=193.606,P＜0.001, there was a statistical difference; the between-subjects effect test:F=7.965,P＜0.05, there was a statistical difference.After pairwise comparison, there was no statistical difference in pain scores between the 2 groups at 6 h and 1 d after surgery (P>0.05) (Table 2).

Comparison of Complications after 7 Days of Treatment

The treatment group had fewer complications and shorter hospital stay. The difference was statistically significant (P＜0.05). The results were shown in Table 3.

Comparison of Patient Satisfaction

Satisfaction rate between the 2 groups after 7 days of treatment in the treatment group was 100%,and the control group was 84.4%. According to statistical analysis, there was a significant differencein the total curative effect between the 2 groups(P＜0.05). Patients in the treatment group had high satisfaction. The results were shown in Table 4.

Table 2. Comparison of Pain Scores (, point)

Table 2. Comparison of Pain Scores (, point)

7d after operation The treatment group 45 4.90±2.09 3.86±1.29 2.42±1.05 1.63±0.79 1.17±0.71 0.67±0.51 The control group 45 4.83±2.11 4.17±1.45 3.48±1.43 2.65±0.86 1.73±0.89 1.05±0.65 P value 0.793 0.182 0.000 0.000 0.000 0.000 Group n 6 h after operation 1d after operation 2d after operation 3d after operation 5d after operation

Table 3. Comparison of Complications Between the 2 Groups (, point)

Table 3. Comparison of Complications Between the 2 Groups (, point)

Group n Edema Urinary retention Defecation Sleep Hospitalization stay The treatment group 45 0.03±0.18 0.01±0.13 0.10±0.31 0.02±0.17 4.28±1.57 The control group 45 0.27±0.52 0.25±0.42 0.37±0.56 0.83±0.67 6.47±1.63 P value 0.02 0.01 0.03 0.01 0.008

Table 4. Comparison of Satisfaction Between the 2 Groups (cases)

The Total Efficacy of Analgesia Between the 2 Groups

Total efficacy between the 2 groups after 7 days of treatment in the treatment group was 100.0% and the control group was 88.8%. According to statistical analysis, there was a significant difference in the total efficacy between the 2 groups(P＜0.05). It showed that the total curative effect in the treatment group was significantly better than that in the control group. The results were shown in Table 5.

Table 5. Comparison of Analgesic Effects Between the 2 Groups (cases)

Tramadol injection was used as a salvage analgesia in this study, and neither group was used.

DISCUSSION

The incidence of anorectal diseases accounted for 50.1% of the population, and 98.09% of them had hemorrhoid symptoms. Mixed hemorrhoids were the most common. Surgery was a direct and rapid treatment method. However, postoperative pain has always been a problem that patients fear and doctors have concerns on. Although western medicine has good analgesic effects, medicine control and its adverse reactions and side effects require us to be cautious when using it. Pain add-ons such as edema and constipation affect wound healing, and at the same time increase the psychological burden of patients. These conditions are falsely transmitted.Patients are unwilling to seek medical treatment,resulting in more and more severe symptoms.Life-threatening still fears surgery. In the end, the patients cannot avoid treatment, and even produce psychological shadows[2].

Multi-modal analgesia is a new concept of analgesia developed based on the concept of rapid rehabilitation surgery[3-5]. Studies have shown that perioperative treatment under the guidance of the concept of Enhanced Recovery After Surgery(ERAS) can effectively promote postoperative gastrointestinal function recovery, reduce postoperative complications, reduce postoperative pain, shorten the patient's postoperative hospitalization time, reduce hospitalization costs[6],and greatly improve the patient experience. The management of postoperative pain is the key to the ERAS concept. Based on this, multi-modal analgesia came into being, aiming to minimize postoperative pain, reduce medicine use, and promote rapid postoperative recovery of patients.Although there are many reports on the use of multimode management of pain after mixed hemorrhoid surgery[7-11], the trade-off of the pros and cons of the mixed treatment of multiple western medicines is still inconclusive, and it also violates the safety concept of ERAS. Traditional Chinese medicine has the advantages of non-addiction, less toxic and few side effects, and with its concept of "blockage leads to pain", a variety of external treatment methods can be used to "unblock pain", such as acupuncture,fumigation, and ear pressing. The above methods are effective in pain control[12-14]. Therefore, the combined effect of TCM multi-modal analgesia is worth looking forward to.

InSpiritual Pivot · Questions and Answers,"The ear is the place where the tendons of all channels converge". "The five zang-organs (heart,liver, spleen, lungs and kidneys) and the six fu-organs (gallbladder, stornach, largein testine,small intestine, bladder and sanjiao), the twelve meridians have collaterals in the ears." Ear-points pressing therapy is used to relieve spasm and pain through unblocking meridians and regulating Qi and blood[15-16]. The ear-points of anus, rectum,sympathetic, subcortical, and Shenmen are selected to reduce edema and pain. InSpiritual Pivot Beginning and Ending, "In chronic disease,evil-Qi has penetrated deep into the body. To use needling therapy to treat such a disease, the needles should be inserted deeply and retained for a longer period of time". Chengshan point can treat hemorrhoids and analgesia. Our department uses 3-0 absorbable micro-Qiao thread as the catgut. It is made of collagen material. The main components are glycolic acid and lactic acid. Each section of one cm is catgut in Chengshan acupoint, which could be absorbed after about one month, and continuous stimulation will be effective. These two methods are long-acting analgesia. In this study, the Chinese materia medica for sitting bath prescription Zhixiao Powder was derived from modified Huanglian Jiedu Decoction (黃連解毒湯). Fu Xiaochun, Chen Hong[17-18]found that Huanglian Jiedu Decoction can reduce the level of inflammatory factors, so as to achieve the role of anti-infection and protection of wounds. This prescription is effective for clearing away heat,detoxifying, removing dampness and removing blood stasis. 38-42 ℃[19]is the most suitable bath temperature. Along with effective drugs, this approach can dredge the meridians, smooth the blood, and relieve or disappear pain. Mayinglong Shexiang Zhichuang Ointment for external use is designed to protect the wound mucosa and prevent external stimuli from causing sensitive wounds.Electro-acupuncture replaces artificial acupuncture therapy by adjusting the frequency, amplitude,intensity, and duration of the current. Electrical physical stimulation acts on acupoints to adjust the body's efficiency and achieve the purpose of analgesia. Baliao acupoints can effectively relieve postoperative urine retention and wound edge edema[20]. These three methods are short-acting analgesia.

In this study, the above-mentioned five methods combination of TCM multi-modal external analgesia was used as the treatment group. This strategy combines long-acting and short-acting, local and overall, learning from strong points to make up for shortcomings, and exerting analgesic effects.Compared with traditional western medicine, pain is significantly relieved. The incidence of complications is low, and the length of hospitalization is shortened.The patient is satisfied, and the curative effect is good, all of which are statistically significant and worthy of clinical promotion. After referring to the literature, it is found that this method is rarely reported. Some literature[21]pointed out that oral administration of Chinese materia medica and external treatment can relieve postoperative anal pain. The pure external treatment in this study avoids the bitterness of direct oral administration of Chinese materia medica and is easier to accept,with more advantages. This study is still blank in China, and it makes up for the shortcomings of TCM surgical analgesia after anorectal surgery.

The purpose of this study is to discover a safe, effective and practical analgesic strategy for postoperative pain of mixed hemorrhoids to establish an analgesic program that is easy to promote,with fewer complications, fewer side effects and a wide range of applications, which can improve the recovery patients' quality of life after surgery,improve the quality of patients' medical treatment and experience of medical treatment, in order to better serve patients, and at the same time conduct useful discussions on the modern research of TCM treatment principles and methods.

The sample size this study is slightly small,which is only a preliminary observation and has not reached the molecular level. Further large samples and long-term studies are needed.